What is the FSSAI No Objection Certificate and How Is It Obtained?

The FSSAI No Objection Certificate is a mandatory pre-import clearance required for food products containing ingredients that do not have an established standard under Indian food law, including novel food ingredients. Without a valid NOC the consignment cannot be cleared at an Indian port regardless of the product's safety profile in other markets. The NOC must be obtained before shipment and not after the arrival.

What is the FSSAI NOC?

The The Food Safety and Standards Authority of India (FSSAI) No Objection Certificate is an administrative clearance issued by FSSAI to permit the import of a food product that either contains a novel food ingredient or uses a food additive not yet standardised under Indian regulations or falls into a product category for which no Indian food standard has been notified. The NOC is not a product registration but a one-time or category-specific permission establishing that the product has been reviewed and is not objected to by FSSAI for import purposes.

The Food Safety and Standards Act, 2006 and the Food Safety and Standards (Import) Regulations, 2017 provides for the NOC mechanism. Regulation 3(5) of the Import Regulations provides that food articles containing ingredients not covered under existing Indian food standards require prior clearance from FSSAI before they can be imported. The Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2022 define the category of novel food and prescribe the requirements applicable to such products including the need for NOC before commercial import.

A novel food ingredient under Indian law is defined as a food or food ingredient that does not have a history of significant human consumption in India or that is produced by a method not previously used for food production. The scope of what qualifies as novel food under Indian regulation may differ from the EU Novel Food Regulation or FDA GRAS classifications. A product that circulates freely in other markets may still require an NOC in India.

The NOC is also issued for food products in categories where no Indian standard has been notified, giving temporary permission for the product to enter India on the basis of an internationally recognised standard such as Codex Alimentarius, while FSSAI develops a domestic standard. The NOC is product-specific and has a defined validity period.

Implications for businesses

For foreign food manufacturers and exporters, a product that is standard in its home market such as a protein supplement using a novel plant source or a fortified food using a micronutrient not yet permitted under FSSAI standards, requires an NOC before a single unit can legally enter India. The NOC application is to be supported by scientific safety data including toxicological studies, history of consumption in other countries, compositional data and evidence of regulatory approval in other jurisdictions.

For Indian importers and distributors, the NOC obligation is a pre-transaction due diligence requirement. The importer must determine whether the product requires an NOC before entering into any supply agreement for a new product or otherwise risk having the consignment held at port. A retrospective NOC application filed after goods have been detained will not result in release of those goods.

How the FSSAI NOC is obtained

The NOC application is filed through the FSSAI online portal (https://foscos.fssai.gov.in/apply-for-lic-and-reg). The application must be filed by the Indian importer and the foreign manufacturer typically provides the technical documentation.

The application includes the product specification sheet, a complete list of ingredients with their concentrations, a certificate of analysis from an accredited laboratory, evidence of the product's regulatory approval or safe use in other countries, relevant safety data including toxicological studies where required, the proposed label artwork for the India-specific version of the product and a declaration from the importer confirming the product's intended use.

FSSAI reviews the application and may seek clarification or additional data from the applicant. The review process involves FSSAI's scientific panels and timelines vary. Processing times of three to six months are common for straightforward applications. Applications involving genuinely novel ingredients with limited global regulatory precedent can take significantly longer. During the review period, the product cannot be imported.

Once the NOC is granted, it must be quoted at the time of import filing on ICEGATE and presented to the authorised Food Safety Officer at the port.

Legality and risks

Importing a food product that requires an FSSAI NOC without having obtained that NOC constitutes a violation of Regulation 3 of the Food Safety and Standards (Import) Regulations, 2017 and Section 25 of the FSS Act. FSSAI's laboratory testing under the Yellow or Red Channel will often identify the ingredient in question, at which point the consignment is detained and an import violation is recorded. Section 59 applies where the product is assessed as substandard food. Section 63 applies where food is imported without the required regulatory clearance, with penalties including fines up to Rs 5 lakh and imprisonment up to six months. Where the non-compliant import involves a product that poses a risk to human health, the more serious provisions of Section 27 of the FSS Act dealing with unsafe food may be invoked.

At the port, a consignment is subject to detention and a rejection order for the want of NOC where necessary. The Food Safety Officer has no discretion to release the goods conditionally pending a retrospective NOC application. The importer must either re-export the goods at their own cost within a specified period or apply for permission to destroy the consignment.

Word of counsel

Importers should engage with FSSAI before transaction planning is finalised, when a product's NOC status is uncertain. FSSAI has in practice provided informal guidance to importers and their consultants on whether a specific product is likely to require an NOC and what the documentary requirements will be before a formal application is filed.

Using pre-application engagement before the supplier agreement is signed, not after the product has been manufactured to Indian specifications, to scope the dossier correctly can save months of preparation cost on an application that was never going to succeed.

A CHA presented with a product that is unusual in the Indian market should flag the potential NOC requirement and advise the client to verify before shipment..

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